Prevention of Glucocorticoid induced impairment of bone metabolism – A Randomized, Placebo-Controlled, Single Centre Clinical Trial

Sahlgrenska University Hospital0 个研究点目标入组 50 人开始时间: 2021年3月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Healthy men and women, 18-45 years old.
•Stated availability throughout the entire study period.
•Ability to understand study instructions and willingness to adhere to the protocol.
•Signed informed consent.
•Have received full immunisation against Covid-19
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 45
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•History of diabetes or glucose intolerance, defined as an abnormal oral glucose tolerance test (OGTT).
•Obesity, BMI>30 kg/m2
•History of adrenal disease or impairment.
•Previous (within the last 5 years) or current use of antiresorptive therapy, including systemic hormone therapy (estrogen), bisphosphonates, strontium ranelate or denosumab.
•Participation in other clinical trials.
•Current antibiotics treatment or within the last 2 months prior to inclusion.
•Current and within the past 2 months use of probiotic supplement.
•Untreated hyperthyroidism or hyperthyroidism within the last 5 years.
•Known untreated hyperparathyroidism.
•Rheumatoid arthritis.
•Diagnosed with disease causing secondary osteoporosis, including chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes mellitus.
•Recently diagnosed malignancy (within the last 5 years).
•Systemic skeletal disease (including e.g. Paget’s disease and osteogenesis imperfecta).
•Any systemic disease that could affect bone loss, as judged by the investigator.
•Oral corticosteroid use.
•History of peptic ulcer.
•Diagnosed osteoporosis.
•Current smoking or other use of nicotine containing products.
•Pregnancy.

发起方

Sahlgrenska University Hospital